U.S. patent application number 10/528422 was filed with the patent office on 2006-05-11 for surgical scalpel with retractable guard.
Invention is credited to Bruce Leigh Kiehne.
Application Number | 20060100650 10/528422 |
Document ID | / |
Family ID | 32031296 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060100650 |
Kind Code |
A1 |
Kiehne; Bruce Leigh |
May 11, 2006 |
Surgical scalpel with retractable guard
Abstract
A safety scalpel blade assembly adapted for attachment to a
handle (12), the assembly comprising a scalpel blade (10) and guard
(11) which extends at least about the cutting edge of the blade
(10), the guard (11) having attachment means to lock the blade to
the guard as the assembly is being attached to the handle and which
releases the blade from the guard when the blade is attached to the
blade carrier on the handle. Improvements include a removable
safety tab (60) on the guard (11), means (68,71) to prevent the
blade guard (11) lifting relative to the handle (12), a safely
catch (75) to prevent excessive retraction of the guard (11) and
location means (80,82) to locate the guard (11) in the extended and
retracted positions.
Inventors: |
Kiehne; Bruce Leigh;
(Queensland, AU) |
Correspondence
Address: |
Hoffman Wasson & Gitler
2461 South Clark Street
Suite 522 - Crystal Center
Arlington
VA
22202
US
|
Family ID: |
32031296 |
Appl. No.: |
10/528422 |
Filed: |
September 10, 2003 |
PCT Filed: |
September 10, 2003 |
PCT NO: |
PCT/AU03/01187 |
371 Date: |
September 21, 2005 |
Current U.S.
Class: |
606/167 |
Current CPC
Class: |
A61B 2017/32113
20130101; A61B 17/3213 20130101 |
Class at
Publication: |
606/167 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 20, 2002 |
AU |
2002951534 |
Jul 22, 2003 |
AU |
2003903812 |
Claims
1. A safety scalpel blade assembly adapted for attachment to a
handle of the type which has a blade carrier in the form of a
finger, the assembly comprising a scalpel blade which can be of
conventional manufacture, the scalpel blade having a slot to allow
the blade to be attached to the blade carrier on the handle, and a
guard which extends at least about the cutting edge of the blade,
the guard having attachment means to lock the blade to the guard as
the assembly is being attached to the handle and which releases the
blade from the guard when the blade is attached to the blade
carrier on the handle, and a removable tab on the guard having a
portion which can be gripped by a person.
2. The assembly as claimed in claim 1, wherein the removable tab
has a head portion and a tail portion, the head portion extending
forwardly of the blade assembly, and the tail portion extending at
least partially into a slot which is present in the guard.
3. The assembly as claimed in claim 2, wherein the removable tab is
attached to the guard via at least one breakable portion.
4. The assembly as claimed in claim 3, wherein the breakable
portion comprises a first breakable portion (a first neck) and a
second breakable portion (a second neck).
5. The assembly as claimed in claim 4, wherein the first breakable
portion is closer to the head portion of the removable tab and
breaks more easily than the second breakable portion.
6. The assembly as claimed in claim 2, comprising anti-lift means
to reduce the ability of the blade guard from lifting relative to
the handle.
7. The assembly as claimed in claim 6, wherein the anti-lift means
comprises an engagement means on the handle which engages the
guard.
8. The assembly as claimed in claim 7, wherein the engagement means
comprises an elongated rib or rail in the handle, and a
corresponding groove or slot in the guard (or vice versa) such that
the guard can slide between the forward and the retracted position
but is held against being lifted by the engagement of the rib or
rail in the groove or slot.
9. The assembly as claimed in claim 2 comprising a safety catch to
prevent excessive retraction of the guard, the safety catch being
positioned on a forward part of the guard and comprising a
projection.
10. The assembly as claimed in claim 2 comprising a location means
to positively locate the guard in the extended position and the
retracted position.
11. The assembly as claimed in claim 10, wherein the location means
comprises at least one projection which releasably engages in at
least one recess when the guard is in the extended position and the
retracted position.
12. A safety scalpel assembly comprising a scalpel blade attached
to a handle of the type which has a blade carrier in the form of a
finger, the assembly comprising a scalpel blade having a slot to
allow the blade to be attached to the blade carrier on the handle,
and a guard which extends at least about the cutting edge of the
blade, the guard having attachment means to lock the blade to the
guard as the assembly is being attached to the handle and which
releases the blade from the guard when the blade is attached to the
blade carrier on the handle, and anti-lift means to reduce the
blade guard from lifting relative to the handle, the anti-lift
means comprising an elongate recess in the blade guard which is
adapted to engage a rib on the handle.
13. A safety scalpel assembly comprising a scalpel blade attached
to a handle of the type which has a blade carrier in the form of a
finger, the assembly comprising a scalpel blade which can be of
conventional manufacture, the scalpel blade having a slot to allow
the blade to be attached to the blade carrier on the handle, and a
guard which extends at least about the cutting edge of the blade,
the guard having attachment means to lock the blade to the guard as
the assembly is being attached to the handle and which releases the
blade from the guard when the blade is attached to the blade
carrier on the handle, and a safety catch to prevent excessive
retraction of the guard, the safety catch being positioned on a
forward part of the guard and comprising a projection.
14. A safety scalpel assembly comprising a scalpel blade attached
to a handle of the type which has a blade carrier in the form of a
finger, the assembly comprising a scalpel blade which can be of
conventional manufacture, the scalpel blade having a slot to allow
the blade to be attached to the blade carrier on the handle, and a
guard which extends at least about the cutting edge of the blade,
the guard having attachment means to lock the blade to the guard as
the assembly is being attached to the handle and which releases the
blade from the guard when the blade is attached to the blade
carrier on the handle, and a location means to positively locate
the guard in the extended position and the retracted position.
Description
FIELD OF THE INVENTION
[0001] This invention relates to various improvements to a surgical
scalpel which has a retractable guard to reduce the incidence of
sharps injury.
[0002] The invention will be described with reference to a surgical
scalpel but it should be appreciated that the invention can be
construed broadly enough to cover any other type of cutting
implement which requires safe handling procedures.
BACKGROUND ART
[0003] Surgical scalpels or surgical knives which are in commercial
use have a handle and a disposable blade. The blade can be detached
from the handle and disposed of by deposit in a special container
which can thereafter be handled with reduced hazard of sharps
injury.
[0004] A sharps injury means any cutting or penetrating object that
can be reasonably anticipated to penetrate the skin or other part
of the body to result in an exposure incident which includes
occupational exposure to blood and other potentially infectious
materials. Clearly, this covers scalpels and other types of
surgical knives.
[0005] The commercially available scalpels which have a disposable
blade generally have reusable handles. The handle can be sterilised
by autoclaving and reused, and these handles are usually formed
from metal.
[0006] The surgical blade comes packaged in a protective foil. The
foil is carefully opened to expose the blade. The blade is then
held between thumb and finger and carefully attached to an
extending projection of finger on the handle. Upon completion of
the surgical procedure, the blade is either manually detached from
the handle and placed in a sharps bin, or the handle with the blade
is inserted into a container which breaks off the blade.
[0007] It can be seen that attachment of the blade to the handle is
a hazardous procedure and can easily result in a sharps injury. If
the blade is manually detached, this can also result in a sharps
injury which is even more hazardous as the blade may be
contaminated.
[0008] During surgical use, the scalpels can accidentally cut the
surgeon's fingers, or the fingers of nurses and other support
persons in the operating theatre. As well, operating personnel can
be accidentally cut when the scalpel is passed between
personnel.
[0009] To partially mitigate against accidental sharps injuries in
handling the scalpel, it is known to provide a retractable blade
guard. The blade guard is attached to the handle, and can be
manually pushed between an extended blade guarding position, and a
retracted blade exposed position Thus, blade guards attached to
scalpel handles are known.
[0010] These blade guards have some disadvantages. Firstly, by
being part of the handle, the handle must be thoroughly cleaned
from any blood and tissue after use, if the handle is to be reused.
The blade guard can catch and contain tissue, congealed blood, and
the like in the various nooks and cavities in the blade guard and
it is extremely difficult to ensure that the blade guard is
absolutely spotlessly clean to allow the handle with the attached
blade guard to be reused. To allow the handle to be reused many
times, the blade guard must be fairly robust and this can result in
the guard being of fairly complex manufacture, quite bulky, and
quite expensive.
[0011] A second disadvantage with this arrangement is that the
blade guard cannot protect against initial attachment of the
sterile blade to the handle. That is, the blade guard must be fully
retracted to expose the projection or finger on the handle to which
the blade is attached. The blade must be attached in the usual
manner which is to initially remove it from its protective foil and
then physically attach it to the handle. Thus, existing blade
guards do not reduce or eliminate sharps injuries which can result
in initial attachment of the blade. As well, these guards do not
protect against removal of the blade from the handle.
[0012] Our earlier international patent application WO 01/05312
described a surgical scalpel with a retractable guard. The device
overcame many of the above-mentioned disadvantages.
[0013] However, attachment of the blade to the handle could still
risk a sharps injury especially if the person attaching the blade
was inattentive or very junior.
[0014] With larger blades and handles there was the possibility
that the guard could "pop off" the handle when retracted due to
some flexibility in the larger guard.
[0015] It was also possible to pull the guard back too far and to
pull the guard off the handle.
[0016] When the guard was retracted to expose the blade and
extended to cover the blade, there was the possibility of
insufficient retraction and extension which could cause a portion
of the blade to be exposed [with insufficient extension] or only
partial exposure of the blade cutting edge [with insufficient
retraction]. It was also possible for the guard to inadvertently
move during use. Thus a visual check was needed. However there
would be an advantage if the fully retracted position and the fully
extended position could be sensed without constant visual checking,
and/or if these positions could be lightly "locked" in place.
OBJECT OF THE INVENTION
[0017] The present invention is directed to improvements with
respect to a surgical scalpel with a retractable guard, and
particularly to improvements in respect of the device described in
our earlier international patent application.
[0018] The present invention is directed to improvements to a guard
assembly which contains a blade attached to a blade guard. The
assembly can be packaged within a sterile foil (similar to
conventional blades). The assembly can be removed from the foil and
can be safely handled with little risk of the blade cutting the
person, and the assembly can be attached to a scalpel handle with
the blade guard in place.
[0019] When the assembly is attached to the scalpel handle, the
blade guard can be retracted fully or partially to expose the
blade. When the surgical procedure is finished, the blade guard can
be pushed back over the blade and the blade and blade guard can be
removed from the handle for safe disposal. In this arrangement, the
handle itself does not keep the blade guard as the guard is
disposed with the blade after use.
[0020] With this arrangement, there is reduced likelihood of sharps
injuries in attachment of a blade to the handle. As well, the
handle does not keep the guard which means that the handle can be
more easily cleaned and sterilized for reuse. The guard can stay
with the blade when the blade is removed which reduces the
incidence of sharps injury when removing the blade from the
handle.
[0021] In one form, the invention resides in a means to improve the
method of attachment of the blade assembly to a handle.
[0022] In this form, the invention comprises the provision of a
removable tab on the blade assembly which can be removed after the
blade has been attached to the handle and prior to exposing the
blade by retracting the guard.
[0023] Thus, one form of this invention comprises a safety scalpel
blade assembly adapted for attachment to a handle of the type which
has a blade carrier in the form of a finger, the assembly
comprising a scalpel blade which can be of conventional
manufacture, the scalpel blade having a slot to allow the blade to
be attached to the blade carrier on the handle, and a guard which
extends at least about the cutting edge of the blade, the guard
having attachment means to lock the blade to the guard as the
assembly is being attached to the handle and which releases the
blade from the guard when the blade is attached to the blade
carrier on the handle, and a removable tab on the guard having a
portion which can be gripped by a person.
[0024] Suitably, the removable tab has a head portion and a tail
portion. The head portion suitably extends forwardly of the blade
assembly. The tail portion suitably extends at least partially into
a slot which is present in the guard.
[0025] Suitably, the removable tab is attached to the guard via at
least one breakable portion. Suitably, a plurality of breakable
portions are provided. These breakable portions are preferably on
the tail portion of the removable tab.
[0026] Suitably, the breakable portions comprise a first breakable
portion (a first neck) and a second breakable portion (a second
neck). It is preferred that the first breakable portion is closer
to the head portion of the removable tab and can break more easily
than the second breakable portion. Thus, the first breakable
portion may be sized for immediate breakage. The second breakable
portion may be more difficult to break and may require both a
twisting action and a leveraged action against the underside of the
blade to break to ensure that the head of the safety tab has moved
sufficiently away from the blade exposure to be safely operated by
hand.
[0027] Thus the function of the tab can be to initially prevent
retraction of the guard and exposure of the blade, until the tab is
removed after which the guard can be retracted and the blade
exposed. Thus the tab provides an improvement to the invention by
preventing inadvertent or premature exposure of the blade.
[0028] The head portion of the removable tab can either be gripped
by a person or may be placed against a solid surface and pushed,
both options allowing the tab to be removed and allowing the guard
to be attached to the handle with a reduced likelihood of being cut
by the blade.
[0029] In another form the invention resides in an improvement to a
surgical scalpel with a retractable guard and which contains a
blade assembly, the blade assembly comprising a blade and a blade
guard, the improvement comprising means to reduce the ability of
the blade guard from lifting relative to the handle.
[0030] This improvement overcomes a disadvantage with earlier
devices and especially earlier devices which comprise a larger
handle and a relatively large guard. The disadvantage was that is
the guard had a degree of flexibility and could inadvertently be
removed from the handle thereby presenting a sharps hazard
situation.
[0031] In one form, the means can comprise an engagement means on
the handle and which engages the guard. The engagement means may
comprise an elongated rib or rail in the handle, and a
corresponding groove or slot in the guard (or vice versa) such that
the guard can slide between the forward and the retracted position
but is held against being lifted by the engagement of the rib or
rail in the groove or slot. Of course, other means to prevent the
guard from being lifted relative to the handle are envisaged.
[0032] Another means to prevent the guard from being inadvertently
removed may comprise a means to prevent the guard from being
retracted too far thereby creating the possibility that the guard
can be pushed out of engagement with the handle.
[0033] In one form, this means may comprise an engagement means
such as a safety catch which prevents excessive retraction of the
guard. The safety catch may be provided on the guard can preferably
on a forward portion of the guard. The safety catch may comprise a
peg or similar type of member.
[0034] Another improvement to the scalpel with retractable guard
comprises a means to positively locate the guard in the extended
position and the retracted position. The means may comprise at
least one projection which can releasably engage in at least one
recess when the guard is in the extended position and the retracted
position. The arrangement may be such that an audible "click" is
heard when the guard is in the extended position or the retracted
position, or that a tactile response is felt.
[0035] In each improvement, the scalpel blade assembly may be of
the type described in our earlier international patent application
and may comprise a scalpel blade assembly comprising a scalpel
blade, a guard which extends at least about the cutting edge of the
blade, and releasable attachment means to releasably attach the
blade to the guard, the attachment means being operable between a
locking position where the blade is held relative to the guard such
that the cutting edge is protected by the guard, and a free
position where the blade can slide out of the guard.
[0036] In a more particularised form, the safety scalpel blade
assembly which is able to be attached to a handle of the type
comprises a blade carrier in the form of a finger, the assembly
comprising a scalpel blade which can be of conventional manufacture
and which has a slot which allows the blade to be attached to the
blade carrier on the handle, and a guard which extends at least
about the cutting edge of the blade, the guard having attachment
means which locks the blade to the guard as the assembly is being
attached to the handle thereby preventing the blade from cutting a
person, but which releases the blade from the guard when the blade
is attached to the blade carrier on the handle.
[0037] In another form, the invention resides in improvements to a
scalpel comprising a scalpel blade assembly and a handle, the
scalpel blade assembly having: a scalpel blade, a guard which
extends at least about the cutting edge of the blade, and
releasable attachment means to releasably attach the blade to the
guard, the attachment means being operable between a locking
position where the blade is held relative to the guard such that
the cutting edge is protected by the guard, and a free position
where the blade can slide out of the guard, the handle having:
[0038] a portion which is releasably lockable to the blade, the
handle further having guide means which engages with the guard when
the handle is attached to the blade to allow the guard to slide
along the guide means on the handle between a retracted position
where at least a portion of the cutting edge of the blade is
exposed, and an extended position where the cutting edge of the
blade is protected,
[0039] the scalpel further having means to move the attachment
means to its free position when the handle is attached to the
blade, and at least one improvement as described above.
[0040] The scalpel blade assembly has the scalpel blade initially
attached to a blade guard. The assembly can be packed in a sterile
foil and the foil can be opened to safely remove the blade and the
blade guard. The assembly can then be attached to a scalpel handle
and thereafter the guard can be retracted to-expose the scalpel
blade.
[0041] The scalpel blade can be of various types depending on the
surgical procedure to be carried out. It is usual for the blade to
be elongate and to have a forward cutting edge. The blade body is
provided with an elongate slot extending therethrough and the slot
allows the blade to be attached to a projection or finger on the
handle. This arrangement is entirely conventional. The invention is
envisaged to cover surgical devices which may be other than a blade
but which also are attachable to a handle and which require safe
handling procedures.
[0042] The guard extends at least about the cutting edge of the
blade to protect against sharps injury. The guard may be formed
from plastics material although other materials are envisaged. As
the blade assembly is disposed of after use, it is preferred that
the guard is made of fairly inexpensive material which is however
still suited for use and which can be sterilised.
[0043] The guard can extend substantially around the blade to form
a shroud or sleeve. The forward end of the guard (that is the end
where the front of the blade sits) should be open or have a
passageway to allow the blade to extend from the guard. To
facilitate attachment of the blade/guard assembly to the handle,
the guard may be required to have an opening or slot to allow the
handle to be attached to the blade while the guard is still in
place, and to allow the guard to be retracted from the blade when
the blade is attached to the handle.
[0044] The assembly has a releasable attachment means. The
releasable attachment means functions to initially attach the blade
to the guard such that when the blade/guard assembly is removed
from its protective package, the blade does not inadvertently fall
out of the guard or expose a cutting edge. The attachment means can
also function to hold the blade in the guard when the blade is
removed for disposal. In one form, this can be achieved by a
projection or button on the guard which extends into the slot in
the blade body (the slot being where the handle attaches to the
blade).
[0045] The projection or button therefore prevents the blade from
inadvertently sliding out of the guard and presenting a cutting
edge.
[0046] If desired, the guard may be provided with a further
projection, or fin which extends into the slot in the blade and can
function to prevent the blade from "rattling" in the guard.
[0047] The releasable attachment means may also be slightly biased,
inter alia to push the blade against a wall of the guard again to
prevent the blade from rattling or exhibiting undesired movement in
the guard.
[0048] The blade assembly can be attached to a scalpel or knife
handle. The knife handle can have a forward projection or finger
which has a profile to allow it to releasably lock to the slot in
the blade. This arrangement is known in the art. The handle can be
provided with means to release the blade from the guard when the
handle is attached to the blade. In one form, the projection or
finger on the handle can have a profile such that when it attaches
to the blade, it also releases the blade from the guard thereby
allowing the guard to be retracted to expose the blade.
[0049] The handle is provided with guide means to engage with the
guard and to allow the guard to slide between retracted and
extended positions. The guide means can be in the form of a recess
in the handle in which the guide slides.
[0050] The guard can be retracted from the blade to expose various
lengths of the blade. For instance, means may be provided to allow
the guard to be releasably locked or held in various retracted
positions to expose various lengths of the blade. This allows the
cutting depth of the blade to be adjusted, and can also ensure that
only a necessary amount of blade is exposed with the remainder of
the blade still being protected by the guard, the purpose being to
further minimise accidental injury.
BRIEF DESCRIPTION OF THE DRAWINGS
[0051] Embodiments of the invention will be described with
reference to the following figures in which
[0052] FIG. 1 is an exploded view of a known scalpel showing the
scalpel blade, the blade guard, and the scalpel handle.
[0053] FIG. 2 shows the known scalpel blade assembly with the blade
initially held within the guard.
[0054] FIG. 3 shows the known blade attached to the handle with the
guard in the retracted position exposing the blade.
[0055] FIG. 4 is an enlarged view of the known blade guard
illustrated in FIG. 1.
[0056] FIGS. 5A-5C show top, bottom and section views of a known
blade guard according to an alternative embodiment.
[0057] FIGS. 6A-6B illustrates a known blade guard.
[0058] FIGS. 7A-7G illustrates a known guard according to a second
embodiment.
[0059] FIG. 8. Illustrates a scalpel having a blade assembly
attached and showing a safety tab which comprises an
improvement.
[0060] FIG. 9. Illustrates the safety tab in greater detail.
[0061] FIG. 10. Illustrates a top view of the scalpel of FIG.
8.
[0062] FIG. 11. Illustrates a side view of the scalpel of FIG.
8.
[0063] FIG. 12. Illustrates the safety tab being removed from the
guard.
[0064] FIG. 13. Illustrates the safety tab being removed from the
guard.
[0065] FIG. 14. Illustrates a top view of the scalpel having the
safety tab being removed from the guard.
[0066] FIG. 15. Illustrates the safety tab completely removed.
[0067] FIG. 16. Illustrates a further improvement which comprises a
handle provided with engagement means to prevent the guard from
being lifted out of the recess in the handle.
[0068] FIG. 17. Illustrates the handle of FIG. 16 with the guard
attached.
[0069] FIG. 18. Illustrates a section view of the guard.
[0070] FIG. 19. Illustrates a section view of the handle in the
recessed area of the handle.
[0071] FIG. 20. Illustrates a front view of the guard according to
this improvement.
[0072] FIG. 21. Illustrates a rear view of the guard of FIG. 20
[0073] FIG. 22. Illustrates the front portion of the scalpel
showing an engagement means to prevent over retraction of the guard
according to a further improvement.
[0074] FIG. 23. Illustrates the scalpel of FIG. 22 with the guard
next to the scalpel.
[0075] FIG. 24. Illustrates the scalpel of FIG. 23 in greater
detail.
[0076] FIG. 25. Illustrates a side view of the scalpel containing
the guard.
[0077] FIG. 26. Illustrates a section view of the front part of a
scalpel according to another improvement which is directed to
allowing the guard to "click" into the forward position and the
rear position.
[0078] FIG. 27. Illustrates a top view of the scalpel of FIG.
26.
[0079] FIG. 28. Illustrates a side view of the scalpel of FIG.
26.
[0080] FIG. 29. Illustrates a perspective view of the scalpel of
FIG. 26.
[0081] FIG. 30. Illustrates a modified guard attached to a
handle.
[0082] FIG. 31. Illustrates the guard of FIG. 30 from the other
side.
[0083] FIGS. 32-37 Illustrate the attachment and removal of the
retractable guard assembly to a scalpel handle.
BEST MODE
[0084] Referring to FIGS. 1 and 7, there are illustrated two
versions of a known scalpel which consist of three main components
being a scalpel blade 10, a blade guard 11, and a scalpel handle
12. Blade 10 is of conventional design and is widely available in
the marketplace. The blade is formed of stainless steel, has a
forward cutting edge, and is provided with an elongate profile slot
13 which is again entirely conventional. Handle 12 has a forwardly
extending projection or finger 14 which is profile and has opposed
side recesses or grooves 15 (only one groove illustrated). Blade 10
is attached to finger 14 with the internal edges of slot 13 sliding
along grooves 15. This is again conventional in the art.
[0085] FIG. 1 illustrates guard 11 which functions to cover or
protect the cutting edge of blade 10 as the blade is attached. That
is, blade 10 can be attached with guard 11 in place such that at no
stage does a person's hand contact the cutting edge of the blade as
the blade is attached to finger 14.
[0086] FIGS. 2 and 8 illustrate two versions of a scalpel blade
assembly which consist of blade 10 and guard 11 with blade 10 now
being entirely within guard 11. Guard 11 in FIGS. 2 and 8 is the
same as guard 11 in FIGS. 1 and 7 except FIGS. 2 and 8 are inverted
views of the guard of FIGS. 1 and 7.
[0087] Guard 11 can be formed from relatively inexpensive plastic
material and is preferably clear or at least translucent such that
that the blade can be seen through the guard. The guard
substantially encompasses the blade to form a shroud or sleeve. The
front 16 of the guard is open such that the guard can be retracted
to expose blade 10. One side wall of guard 11 is provided with an
elongate slot 17 which extends entirely along the side wall from
the front 16 to the rear wall 18 of the guard. The function of slot
17 is to not interfere with retraction of the guard when blade 10
is attached to finger 14.
[0088] Guard 11 has a releasable attachment means which functions
to hold blade 10 in guard 11 (see FIGS. 2 and 8) before the
blade/guard assembly is attached to scalpel handle 12. In the
embodiment of FIG. 2, the releasable attachment means is in the
form of a projection or button 19 which is also illustrated in FIG.
5C. Button 19 sits at one end of a flat finger 20 (see FIG. 1).
Finger 20 is integrally formed with the remainder of guard 11 and
is able to be depressed by virtue of its finger-like quality.
[0089] A protective raised wall 21 extends around finger 20 but
finger 20 is not attached to wall 21 which means that finger 20 can
pivot or be depressed within the confines of wall 21. Wall 21
functions inter alia to protect the rather small finger against
unintentional movement, or damage.
[0090] In the embodiment of FIGS. 7 and 8, the raised wall is not
present. The projection 50 (see also FIG. 12) has a ramped wall 51
extending from finger 20.
[0091] In use, the scalpel blade assembly as illustrated in FIGS. 2
and 8 is assembled and can be placed in a foil package in a manner
similar to current scalpel blades. The assembly can be removed from
a foil package and it can be seen from FIGS. 2 and 8 that button
19,50 holds the blade within guard 11 and therefore the assembly
can be picked up by guard 11 which means that there is little or no
likelihood of the blade causing a stick injury.
[0092] The assembly can then be placed onto finger 14 with finger
14 passing into slot 13 to attach the blade to finger 14. Finger 14
is profile such that when it extends into slot 13, it also pushes
away button 19, 50 against the bias of finger 20. This in turn
releases blade 1 0 from its housing 11. For as long as blade 1 0 is
attached to finger 14, the profile of finger 14 keeps button 19,50
out of slot 13 and therefore prevents button 19,50 from reengaging
with the blade. Upon removal of the blade and guard assembly, the
guard is first pushed to the forward position where it covers the
blade and then the blade is decoupled from finger 14. As soon as
this occurs, button 19, 50 is released and with the bias of finger
20 will re-enter into slot 13 to again hold the blade within the
guard. The blade and guard assembly can now be safely disposed of
in a sharps bin with little or no likelihood of stick injury
resulting.
[0093] Finger 20 is biased to bias button 19, 50 into slot 13. In
FIG. 2, button 19 extends from a larger shoulder portion 22 (more
clearly illustrated in FIGS. 5B and 5C). Shoulder portion 22 is too
large to extend through slot 13 but instead abuts against one side
of the blade. With the biasing action of finger 20, shoulder
portion 22 functions to gently push the blade against one side wall
of guard 11 and prevents the blade from rattling or from exhibiting
unintentional movement. The position of button 19 is such that when
blade 10 is within guard 11 (see FIG. 2), the button is adjacent
the rearpportion of slot 13. This prevents the blade from further
extension out of the guard.
[0094] Movement of the blade in the other direction is prevented as
rear end 18 of guard 11 does not have an open end as does the front
16. Thus, blade 10 is essentially trapped within housing 11 until
such time as the assembly is attached to finger 14 which in turn
pushes button 19 out of engagement with slot 13. In FIGS. 8, 12 and
13, button 50 has opposed shoulder portions 52 which serve the same
function as shoulder portion 22 in FIG. 2.
[0095] Handle 12 has a guide means 23 which in the embodiment is in
the form of a recess 24 on the forward portion of handle 12 and
immediately behind finger 14. The recess is sufficiently long such
that guard 11 can be pulled back to fully expose blade 10. This
fully retracted blade exposing position is illustrated in FIGS. 3
and 9. The recess 24, which forms part of the guide means in handle
12, is configured to accept the shape of guard 11.
[0096] Recess 24 has opposed side walls 25 which guide the opposed
side walls 26 of guard 11.
[0097] Guard 11 has a number of small projections or buttons 27
extending from each side wall 26, and the side walls 25 of recess
24 have corresponding recesses 28. The function of buttons 27 and
recesses 28 is to allow the guard 11 to be retracted along recess
24 and be releasably locked into preset positions where an opposed
pair of buttons 27 click into an opposed pair of recesses 28. The
releasable locking arrangement is such that the surgeon's thumb is
able to slide the guard to release the guard from engagement with
the guide means. However, when the surgeon's thumb is not on guard
11, the guard is held in place sufficiently to prevent it from
inadvertently becoming loose. This arrangement has the advantage
that if only a small part of the cutting blade is required, the
guard can be clicked into an only partially retracted position
thereby still protecting the remainder of the cutting edge of the
blade against stick injury. The guard can also provide a means to
measure the depth of the cut by exposing only a certain length of
the cutting blade.
[0098] The guard has a thumb engageable projection 30 such that a
surgeon can grip the guard by projection 30 and can extend or
retract the guard in a single simple motion. Raised wall 21
prevents the surgeon's thumb from accidentally pushing in finger
20.
[0099] FIGS. 5A-5C and FIGS. 11-13 show variations to the
guard.
[0100] In these variations, the guard has an additional fin 31
which sits in slot 13 of blade 10 and functions to keep the blade
central. Fin 31 is also attached to finger 20 such that it is
pushed out of the way when the blade is attached to the scalpel
handle.
[0101] FIGS. 6A and 6B illustrate a blade guard 35 which is
injection moulded and consists of two halves 36, 37 connected via a
hinge line 38. The guard is moulded in a flat configuration
illustrated in FIG. 6A. The blade 39 (see FIG. 6B) is placed on one
half 37 and the other half 36 is bent via hinge line 38 to overlie
the first half 37. The halves are snap locked together by
projections 40 on one of the halves which engage into recesses 41
on the other half.
[0102] Referring now to FIGS. 8-15 there is illustrated a first
improvement to the known type of scalpel blade assembly described
above. This first improvement is directed to an improvement to the
method of attachment of the blade assembly to the handle with
reduced likelihood of a sharps incident. In the particular
embodiment the improvement comprises a removable tab 60 which
comprises a head portion 61 and a tail portion 62. Head portion 61
comprises a flat member which can be gripped between a person's
fingers or which can be pushed against a hard surface. Tail portion
62 is integrally formed with head portion 61 and is positioned to
at least partially fill slot 17 in guard 11. The slot 17 is
illustrated in FIG. 2.
[0103] Tail portion 62 is attached to the remainder of guard 11 by
a plurality of breakaway portions. In the particular embodiment,
two sets of breakaway portions are provided which comprise a first
breakable portion (a first neck 63), and a second breakable portion
(a second neck 64). Each breakable portion comprises a pair of thin
portions which can be torn away.
[0104] Referring to FIG. 12, the first neck 63 comprises a very
thin portion which can be immediately broken away. Second neck 64
comprises thicker portions which are not as easily broken away.
Thus, initial lifting of head portion 61 will break neck 63 to
allow head portion 61 to be quite easily moved away from the rest
of guard 11. After that, the tab must be twisted and pulled harder
against the underside of blade 10 to allow neck 63 to be broken
thereby allowing the tab to be removed entirely from guard 11. This
ensures that the tab head 61 has moved sufficiently below with the
line of the blade exposure to allow it to be safely operated by
hand. Further pulling of the tab rearwardly will result in guard 11
being retracted to expose blade 10. Thus, the guard can be
initially retracted as the safety tab is removed.
[0105] FIG. 15 shows the tab 60 completely removed from guard 11
and shows how guard 11 has been partially retracted to expose blade
10 in a very safe manner.
[0106] Another improvement to the scalpel is illustrated in FIGS.
16-21. Briefly, this improvement prevents the guard from lifting
out of the handle. The improvement requires modification to the
guard and modification to the handle. Referring to FIGS. 16-21,
there is illustrated a modified handle 65. Handle 65 is provided
with a recess 66. The recess has a side wall 67. Side wall 67 is
provided with a longitudinal rib 68 which is best illustrated in
the section view of FIG. 19. Guard 69 is similar to the guard
described above except that one edge wall 70 of the guard 69 is
provided with a longitudinal recess 71 which is best illustrated in
the section view of FIG. 18. Thus, guard 69 is firmly held in
recess 66 by having rib 68 trapped inside recess 71. This means
that the guard 69 cannot be inadvertently lifted out of the recess
66 in handle 65.
[0107] FIGS. 22-25 illustrate another way to prevent the guard from
being removed from the handle. Again, this improvement requires
modification to the guard and to the handle. Guard 72 (see FIG. 23)
is provided with an engagement means in the form of the safety
catch which prevents guard 72 from being retracted too far
rearwardly and thus possibly able to be retracted out of the recess
74 in handle 73. Specifically, the front of guard 72 is provided
with a peg 75 best illustrated in FIG. 24. Peg 75 is formed
integrally with guard 72 and extends at right angles from the front
end of guard 72 such that peg 75 points towards handle 73 (in use).
Peg 75 will abut against a stop 76 formed in handle 73 when guard
72 is fully retracted. Thus, guard 72 cannot be retracted too far
as peg 75 will prevent this from occurring.
[0108] FIGS. 26-29 illustrate another improvement which is to
provide a positive temporary locking of the guard when in the
forward and the retracted position. In the embodiment, the
arrangement is such to provide an audible "click" sound in the
forward position and the retracted position such that the surgeon
can be more confident of the guard being fully retracted or
extended.
[0109] In the embodiment, this is achieved by providing at least
one projection which can releasably engage with at least one recess
when the guard is in the forward position and the retracted
position. Specifically, the projection (locking bump 80) is
provided of the handle 81 and the recess (location hole 82 is
provided on guard 83. A ramp 84 is provided adjacent a forward part
of the scalpel to lift the guard out of locking bump 80 as the
guard is being retracted. Similarly, a ramp 85 is provided to
lifted guard out of locking bump 80 when the guard is being
extended.
[0110] Referring to FIGS. 30 and 31, there is illustrated a
variation to the scalpel. The scalpel has a handle 90 containing a
forwardly extending finger or nose portion 91 to which the scalpel
blade is attached. The scalpel blade 92 is protected by the guard
93, the guard being substantially as described above. The scalpel
blade 92 and guard 93 are attached to the forwardly extending
finger 91 in the manner described above. This particular variation
allows the guard 93 to be fully retracted and fully extended and
provides an audible "click" when the guard is in the fully
retracted position and the extended position. This allows the
surgeon to retract the guard until the audible click is heard. When
the guard is "clicked" into the retracted position, there is little
likelihood of the guard being inadvertently moved to the forward
position for the reasons described below.
[0111] Guard 93 is made of clear plastic material and contains a
small extending button or projection 95 which is illustrated in
FIG. 30. The button or projection is formed integrally with the
guard 93 and is cylindrical having a diameter of approximately 1 mm
and projecting (away from blade 92) by distance of about 1 mm. This
button can be called the front button.
[0112] Guard 93 is also provided with a rear button 96 which has a
size and shape similar to that of the front button 95, and rear
button 96 is illustrated in FIG. 31.
[0113] The handle 90 is formed of plastic material and contains a
recess 97 to accommodate guard 93 as guard 93 is retracted to
expose blade 92. Recess 97 is formed with a rear hole 98 and a
front hole 99 (both illustrated in FIG. 31). Each hole 98, 99 is
designed to accommodate the respective front button 95 and rear
button 96. Specifically, rear hole 98 accommodates rear button 96
and front hole 99 accommodates front button 95. As a button
overlies a hole, the button is pressed into the hole and gives an
audible "click" sound. Specifically, as guard 93 is retracted to
expose blade 92, in the fully retracted position, the front button
95 passes into the front hole 99 at the same time that the rear
button 96 passes into rear hole 98.
[0114] As guard 93 is retracted to expose blade 92, front button 95
at some stage will strike the front wall portion 102 of handle 90
(see FIG. 30). At this stage, the guard is sufficiently retracted
to expose blade 92. A surgeon can either elect to keep the guard
retracted in this manner and can easily push the guard back over
the front of blade 92 to protect the blade when not required.
However, when in this retracted position, the surgeon can also pull
the guard back to a greater extent which will cause front button 95
to ride over front wall portion 102 and into engagement with front
hole 99. In this fully retracted position, the guard is not easily
(and therefore cannot inadvertently) move back to the blade
protecting position.
[0115] Recess 97 contains a central elongate rib 100 and the rear
of guard 93 is provided with a channel to enable the guard to slide
along rib 100. The sidewalls 101 of recess 97 also guide the guard
into a smooth retracting direction.
[0116] FIGS. 30 to 37 illustrate the attachment and removal of the
protected scalpel blade to the handle. In FIG. 32, the blade 92 is
mounted onto the handle by inserting the handle tip (finger) 91
into the blade slot as described above. The arrangement is then
pulled back onto the handle until an audible click is heard when
the arrangement is pulled back onto the handle to a sufficient
amount. At this stage, the blade is not yet exposed. The safety tab
61 (see FIG. 33 and 34) is bent back and broken off. Only when the
safety tab has been removed is the guard 69 pulled back (see FIG.
35) to expose blade 92. Typically, the person attaching the blade
will have a "dominant" hand and a "free" hand. The guard is first
attached to the handle using both hands (see FIG. 32). The dominant
hand holds the handle and the free hand must be removed from the
vicinity of the blade to prevent being cut. The safety tab 61 is
designed to force the free hand to grip and remove the tab to
prevent the free hand from manipulating the guard, and also ensures
that the free hand is moved away from the blade by the downward
motion of the free hand when tab 61 is removed (see FIG. 34) Guard
69 can be pulled back until an audible "click" is heard which means
that the guard has been fully retracted to expose the blade. The
guard can be pushed forwardly (see FIG. 36) to cover blade 92 and
this can be done repeatedly especially when the scalpel is passed
from one person to another person. To dispose of the blade and
guard, the guard is pushed forwardly and is gently scooped to
remove the blade from the handle. The blade containing the guard
(the blade being covered by the guard and therefore preventing a
sharps hazard) can then be discarded into a sharps container 110
(see FIG. 37).
[0117] It should be appreciated that various other changes and
modifications can be made to the embodiment described without
departing from the spirit and scope of the invention as
claimed.
* * * * *